Method of manufacture of custom cranial remodeling devices by additive manufacturing

ABSTRACT

A method for fabricating a custom cranial remodeling device for correction of cranial deformities in a subject is described. The method comprises generating a three-dimensional head data file for the subject and determining contour lines on the head. The method further comprises automatically generating a modified head shape data file and juxtaposing the modified head shape with the head represented by the three-dimensional head data file having the contour lines thereon. Still further the method includes utilizing the modified head shape data file to generate a shape for a desired custom cranial remodeling device, the shape having an interior surface to contact the head and an outer surface. The method also includes projecting lines outward from the contour lines to the outer surface and utilizing the projected lines to establish cranial remodeling device contour lines for the custom cranial remodeling device.

This application is a continuation of U.S. patent application Ser. No.16/925,700 filed Jul. 10, 2020 which is a continuation of Ser. No.15/474,684 filed Mar. 30, 2017, now U.S. Pat. No. 10,710,356. Thisapplication is related to U.S. Pat. Nos. 10,846,925; 10,703,084;10,726,617; 10,463,525; 10,561,521; 10,603,203; and 10,682,846. Thisapplication is particularly related to U.S. Pat. No. 10,846,925. All theaforesaid Applications and Patents being owned by the Assignee of thisinvention.

The present invention pertains to custom cranial remodeling devicescustom manufactured for subject patients and methods of manufacturingsuch devices.

The applicant of the present invention has pioneered the treatment ofplagiocephaly in infants through the use of cranial remodeling devicesthat are each custom manufactured for each infant patient and haspioneered the customized manufacture of such devices.

One method of manufacturing custom cranial remodeling devices comprisescapturing a three-dimensional digital image of the entirety of apatient's head to produce a digital file of the entire head, processingthe digital file to generate a second digital file that represents athree-dimensional digital image of the entirety of a desired head shapefor the patient, fabricating a life size model of the desired headshape, vacuum thermo-forming a foam liner onto the life size model,vacuum thermo-forming a hard plastic onto the foam liner, generatingtrim lines for the device, projecting the trim lines onto the hardplastic, cutting the trim lines, and manually finishing the trimmedcranial remodeling device.

Each different step in a manufacturing process presents the possibilityof introduction of error or inaccuracy. Accordingly, it is desirable toreduce the number of steps to manufacture custom cranial remodelingdevices.

In addition, a clinician typically captures the three-dimensionaldigital image of the entirety of a patient's head at a clinic and themanufacturing steps occur at one or more other physical locations.Because of the physical separation of the clinic and the manufacturinglocations, the custom cranial remodeling device must be shipped from themanufacturing facility to the clinic resulting in a time delay that ismeasured in days.

Accordingly, it is also desirable to provide point of servicemanufacturing of cranial remodeling devices such that the manufactureoccurs at the clinic location.

Optimally it is desirable to change out cranial remodeling devicesfrequently. By adding a foam liner, the cranial remodeling devices couldbe adjusted by a clinician to accommodate for the patient's growth. Thefoam liner is provided to extend the life of the product.

In addition, the inside foam liner does not always compress evenly undervacuum. When released from vacuum, there is some spring back of thematerial. The result of the spring back may result in the foam layer notretaining conformance to the model.

Accordingly, it is also desirable to manufacture cranial remodelingdevices that are so accurately manufactured and easily manufactured suchthat it is not necessary to include a foam layer.

SUMMARY

An embodiment of apparatus to provide point of service manufacture of acustom cranial remodeling device for correction of cranial deformity ofa subject comprises apparatus disposed at a physical location forcapturing three-dimensional digital data of the head of the subject andgenerating a three-dimensional digital data file representative of thehead; an additive manufacture device located at the same physicallocation; a processor that operates to process the three-dimensionaldigital data file to produce a device file comprising the shape for thecustom cranial remodeling device and to provide the device file to theadditive manufacture device. The additive manufacture device operates toutilize the device file to manufacture the custom cranial remodelingdevice at the physical location.

In various embodiments, the processor is located at one of the samephysical location or at a location physically removed from the physicallocation.

In various embodiments, prior to providing device file to the additivemanufacture device, the processor operates to modify the device file toinclude one or more removable manufacturing supports for the customcranial remodeling device to facilitate additive manufacture of thecustom cranial remodeling device.

In various embodiments, the processor operates to determine a pluralityof different layers for incorporation into the cranial remodeling deviceand provides data for the different layers in the device file, and theadditive manufacture device manufactures the custom cranial remodelingdevice with the plurality of different layers.

In the various embodiments, the processor automatically selects theplurality of different layers to comprise one or both of differentstrength and material properties.

In the various embodiments, the processor automatically selects theplurality of different layers to apply different forces over differentareas of the head.

The processor may select the plurality of different layers such thatnone of the different layers comprises a foam layer.

In an embodiment, the processor operates to generate alignment marks inthe device file for the additive manufacture device to print alignmentmarks on the custom cranial remodeling device to aide fitting the customcranial remodeling device.

The processor may operate to select the plurality of different layerssuch that one of the different layers comprises a foam layer.

In an embodiment, the processor generates guidelines data in the devicefile, and the additive manufacture device utilizes the guidelines datato print guidelines on the custom remodeling device.

In various embodiments, the processor generates electronic sensormanufacture data in the device file, and the additive manufacture deviceutilizes the electronic sensor data to automatically manufacture one ormore corresponding electronic sensors into the custom cranial remodelingdevice.

The processor may generate electronic sensor manufacture data in thedevice file for one or more electronic sensors operable to determinepressure applied to the head when the custom cranial remodeling deviceis worn on the head, and the additive manufacture device utilizes theelectronic sensor data to automatically manufacture one or morecorresponding electronic sensors into the custom cranial remodelingdevice.

In various embodiments, the processor generates electronic sensormanufacture data in the device file, the electronic sensor is operableto confirm that the custom cranial remodeling device is being correctlyworn on the head, and the additive manufacture device utilizes theelectronic sensor data to automatically manufacture one or morecorresponding electronic sensors into the custom cranial remodelingdevice.

In various embodiments, the additive manufacture device may be utilizedto automatically print one or more electronic transducers into thecustom cranial remodeling device.

The one or more electronic transducers may be useable to determine oneor more of tilt and turn of the head, whether the custom cranialremodeling device is being worn, and the frequency of predetermined headmotions.

In various embodiments, the additive manufacture device automaticallyforms components integral with the custom cranial remodeling device. Thecomponents may comprise one or more of apparatus for fastening thecranial remodeling device in place on the head, electronic transducers,and electronic sensors.

In various embodiments, the processor identifies regions on the interiorof the cranial remodeling device where one layer of the plurality oflayers is to contact the head and other regions on the interior of thecranial remodeling device where the interior surface of the cranialremodeling device is to be spaced apart from the head. The additivemanufacture device manufactures the cranial remodeling device with theregions and other regions.

An embodiment of a method for fabricating a custom cranial remodelingdevice for correction of cranial deformities in a subject, comprises:generating a three-dimensional digital data file for the subject at aclinic by capturing a three-dimensional data file representative of thehead of the subject utilizing apparatus operating to capturethree-dimensional data representative of the head, the apparatus locatedat the clinic; utilizing a processor to process the three-dimensionaldigital data file to produce a device file comprising the shape for thecustom cranial remodeling device; and manufacturing the custom cranialremodeling device at the clinic by utilizing an additive manufacturedevice located at the clinic to operate with the three-dimensionaldigital data file.

In various embodiments, the method comprises providing the processor atone of the clinic or a location physically removed from the clinic.

In various embodiments, the method comprises modifying the digital datafile prior to utilizing the additive manufacture device to include oneor more removable manufacturing supports for the custom cranialremodeling device to facilitate additive manufacture of the customcranial remodeling device.

In various embodiments, the method comprises utilizing the processor todetermine a plurality of different layers for incorporation into thecranial remodeling device, and utilizing the additive manufacture deviceto manufacture the custom cranial remodeling device with the pluralityof different layers.

In various embodiments, the processor automatically selects theplurality of different layers to comprise one or both of differentstrength and material properties.

The method may comprise automatically selecting the plurality ofdifferent layers to apply different forces over different areas of thehead.

The method may further comprise selecting the plurality of differentlayers such that none of the different layers comprises a foam layer.

In various embodiments the method comprises utilizing the additivemanufacture device to print alignment marks on the custom cranialremodeling device to aide fitting the custom cranial remodeling device.

The method may comprise selecting the plurality of different layers suchthat one of the different layers comprises a foam layer.

In various embodiments, the method comprises utilizing the additivemanufacture device to print clinician guidelines on the customremodeling device.

In various embodiments, the method comprises utilizing the additivemanufacture device to print clinician guidelines on the custom cranialremodeling device.

In various embodiments, the method may comprise utilizing the additivemanufacture device to print automatically print one or more electronicsensors into the custom cranial remodeling device.

In various embodiments, the method may comprise depositing one or moreelectronic sensors operable to determine the pressure level applied tothe head when the custom cranial remodeling device is worn on the head.

In various embodiments, the method may comprise depositing one or moreelectronic sensors to confirm that the custom cranial remodeling deviceis being correctly worn on the head.

In various embodiments, the method may comprise utilizing the additivemanufacture device to print to automatically print one or moreelectronic transducers into the custom cranial remodeling device.

In various embodiments, the one or more electronic transducers may beuseable to determine one or more of tilt and turn of the head, whetherthe custom cranial remodeling device is being worn, and the frequency ofpredetermined head motions.

In various embodiments, the method may comprise utilizing the additivemanufacture device to automatically form components integral to thecustom cranial remodeling device.

In the various embodiments, the components comprise one or more ofapparatus for fastening the cranial remodeling device in place on thehead, electronic transducers, and electronic sensors.

In various embodiments, the method may comprise utilizing the processorto identify regions on the interior of the cranial remodeling devicewhere one layer of the plurality of layers is to contact the head andother regions on the interior of the cranial remodeling device where theinterior surface of the cranial remodeling device is to be spaced apartfrom the head.

In various embodiments, the method comprises locating apparatus forgenerating a three-dimensional digital data file for the subject at theclinic, locating the processor at the clinic, and locating the additivemanufacture device at the clinic.

An embodiment of a point of service method at a clinic for fabricating acustom cranial remodeling device for correction of cranial deformitiesin a subject, comprises: generating a three-dimensional digital datafile for the head of a subject located at the clinic by capturing athree-dimensional data file representative of the head utilizing digitalimage capture apparatus located at the clinic; utilizing, at the clinic,a processor to process the three-dimensional digital data file at theclinic by: automatically processing the scan data file to generatecontour lines for the custom cranial remodeling device on the scannedhead, automatically processing the scan data file to generate a modifiedhead shape data file, juxtaposing the modified head shape with thescanned head shape having the contour lines, utilizing the modified headshape data file to generate a shape for a desired copolymer cranialremodeling band, projecting lines outward from the contour lines to theouter surface of the desired copolymer cranial remodeling device, andutilizing the contour lines to produce a device file comprising theshape for the custom cranial remodeling device. The method furthercomprises manufacturing the custom cranial remodeling device at theclinic by utilizing an additive manufacture device located at theclinic.

An embodiment of a method for fabricating a cranial remodeling devicefor correction of cranial deformities in a subject comprises generatinga three-dimensional head data file for the head of the subject;identifying predetermined anthropometric reference points on the headrepresented by the three-dimensional head data file; automaticallyutilizing the predetermined anthropometric reference points to calculatecontour lines on the head represented by the three-dimensional head datafile for the cranial remodeling device; automatically generating amodified head shape data file for the head; juxtaposing the modifiedhead shape represented by the modified head shape data file with thehead represented by the three-dimensional head data file having thecontour lines thereon; utilizing the modified head shape data file togenerate a shape for a desired of a cranial remodeling device, the shapehaving an interior surface to contact the head and an outer surface;projecting lines outward from the contour lines to the outer surface;and utilizing the projected lines to establish cranial remodeling devicecontour lines for the cranial remodeling device.

The method may further comprise generating a three-dimensional devicedata file comprising the contoured shape.

The method may further comprise providing the three-dimensional devicedata file to an additive manufacturing device.

The method may further comprise utilizing the additive manufacturingdevice to manufacture the cranial remodeling device from thethree-dimensional device data file.

In various embodiments, the method may comprise utilizing athree-dimensional printer as the additive manufacturing device.

Embodiments of the method may comprise modifying the three-dimensionaldata file by automatically orienting the three-dimensional head datafile to a predetermined plane by first automatically identifying twopredetermined anthropometric points on the head and utilizing the twoanthropometric points to form a horizontal plane to which the head isrotated to produce a standardized oriented head data file for anoriented head shape.

In various embodiments, the method may comprise determiningpredetermined reference points on the head, and automatically selectiveutilizing the predetermined reference points to calculate the contourlines.

The method may comprise generating a three-dimensional device data filecomprising the contoured shape.

The method may further comprise providing the three-dimensional devicedata file to an additive manufacturing device.

The method may comprise utilizing the additive manufacturing device tomanufacture the cranial remodeling device from the three-dimensionaldevice data file.

In various embodiments, the method may comprise utilizing athree-dimensional printer as the additive manufacturing device.

In embodiments, the method comprises capturing digital data for thethree-dimensional head data file from the head.

In embodiments, the method may comprise capturing the digital data withone of digital image capture apparatus and scanning apparatus.

An embodiment of a method for creating a device data file for use by athree-dimensional printer to print a cranial remodeling device forcorrection of a deformed head shape in an infant comprises: generating athree-dimensional data file of the deformed head shape; processing thethree-dimensional data file to generate a three-dimensional modifieddata file for a modified head shape for the infant; utilizing themodified head shape to generate a device data file for a cranialremodeling device; automatically determining predetermined referencepoints on the captured deformed head shape; automatically utilizing thepredetermined reference points to calculate contour lines on thedeformed head shape; projecting lines outward from the contour lines tothe outer surface of the modified head shape; and modifying the modifiedhead shape represented by the device file by utilizing the projectedlines to establish contour lines for the cranial remodeling device inthe device file.

An embodiment of a method for fabricating a cranial remodeling devicefor correction of cranial deformities in a subject comprises: generatinga three-dimensional head data file for the head of the subject;identifying predetermined reference points on the head represented bythe three-dimensional head data file; automatically selectivelyutilizing the predetermined reference points to calculate contour lineson the head represented by the three-dimensional head data file for thecranial remodeling device; automatically generating a modified headshape data file for the head; juxtaposing the modified head shaperepresented by the modified head shape data file with the headrepresented by the three-dimensional head data file having the contourlines thereon; utilizing the modified head shape data file to generate ashape for a desired of a cranial remodeling device, the shape having aninterior surface to contact the head and an outer surface; projectinglines outward from the contour lines to the outer surface; and utilizingthe projected lines to establish cranial remodeling device contour linesfor the cranial remodeling device.

Embodiments of the method may comprise generating a three-dimensionaldevice data file comprising the contoured shape.

Embodiments of the method may comprise providing the three-dimensionaldevice data file to an additive manufacturing device and utilizing theadditive manufacturing device to manufacture the cranial remodelingdevice from the three-dimensional device data file.

Various embodiments of the method comprise modifying thethree-dimensional data file by automatically orienting thethree-dimensional head data file to a predetermined plane by firstautomatically identifying two predetermined anthropometric points on thehead and utilizing the two predetermined anthropometric points to form ahorizontal plane to which the head is rotated to produce a standardizedoriented head data file for an oriented head shape.

Various embodiments comprise determining predetermined anthropometricpoints on the head, and automatically utilizing the predeterminedanthropometric points to calculate the contour lines.

Various embodiments may comprise generating a three-dimensional devicedata file comprising the contoured shape.

Various embodiments may comprise capturing digital data for thethree-dimensional head data file from the head.

Embodiments may comprise capturing the digital data with one of digitalimage capture apparatus and scanning apparatus.

A method for creating a device data file for use by a three-dimensionalprinter to print a cranial remodeling device for correction of adeformed head shape in an infant comprises: generating athree-dimensional data file of the deformed head shape; processing thethree-dimensional data file to generate a three-dimensional modifieddata file for a modified head shape for the infant; utilizing themodified head shape to generate a device data file for a cranialremodeling device; automatically determining predeterminedanthropometric points on the captured deformed head shape; automaticallyutilizing the predetermined anthropometric points to calculate contourlines on the deformed head shape; projecting lines outward from thecontour lines to the outer surface of the modified head shape; andmodifying the modified head shape represented by the device file byutilizing the projected lines to establish contour lines for the cranialremodeling device in the device file.

An embodiment of a custom cranial remodeling device to correct adeformed head of a subject comprises an inner layer shaped to contactthe head of the subject at predetermined areas, the inner layerdeposited by an additive manufacturing device, an outer layer depositedby the additive manufacturing device, and the inner layer and the outerlayer are each formed by the additive manufacture device utilizing adevice data file derived from a subject data file, the subject data filerepresentative of the shape of the deformed head, the device data filedetermining the shape of the cranial remodeling device to correct theshape of the deformed head.

In an embodiment, the device data file is derived from the subject datafile and a modified data file. The modified data file is derived fromthe subject data file and is representative of a modified head shape.

In an embodiment, the device data file is derived by one or moreprocessors: determining contour lines for the custom cranial remodelingdevice on the deformed head shape utilizing the data file; juxtaposing adigital representation of the modified shape on the deformed head shape;projecting the contour lines outward from the deformed head onto themodified shape; and utilizing the contour lines to produce the devicefile.

In various embodiments the inner layer comprises portions positioned tocontact the head at predetermined surface areas of the head.

In various embodiments, the inner layer comprises a plurality ofseparate portions, each portion configured to contact one of acorresponding plurality of areas on the head.

In various embodiments the cranial remodeling device comprises one ormore removable manufacturing supports to facilitate additive manufactureof the custom cranial remodeling device.

In various embodiments of the cranial remodeling device at least oneintermediate layer is provided between the inner layer and the outerlayer. The intermediate layer deposited by the additive manufacturingdevice.

In the various embodiments, the inner layer, the outer layer and theintermediate layer each comprise one or both of different strength andmaterial properties.

In various embodiments the cranial remodeling device comprises alignmentmarks deposited on the cranial remodeling device by the additivemanufacture device, the alignment marks aide fitting the custom cranialremodeling device.

One embodiment comprises a plurality of different layers comprising theinner and outer layers and one or more intermediate layers, theplurality of layers comprising one or more of different strengthproperties, material properties, and configurations, each layer of theplurality of layers is deposited by the additive manufacturing device.

In various embodiments, at least one layer of the plurality of layerscomprises a cellular configuration.

In at least one embodiment, at least one layer of the plurality oflayers comprises carbon fibers integrated therein.

In various embodiments, one or more electronic sensors are manufacturedby the additive manufacture device into the custom cranial remodelingdevice.

Certain embodiments may comprise one or more electronic sensors operableto determine pressure levels applied to the head when the custom cranialremodeling device is worn on the head. The one or more electronicsensors are manufactured into the custom cranial remodeling device bythe additive manufacture device.

Embodiments may comprise one or more electronic sensors operable toconfirm that the custom cranial remodeling device is being correctlyworn on the head. The one or more electronic sensors are manufacturedinto the custom cranial remodeling device by the additive manufacturedevice.

Embodiments may comprise one or more electronic transducers manufacturedinto the custom cranial remodeling device by the additive manufacturedevice. The one or more electronic transducers may be useable todetermine one or more of tilt and turn of the head, whether the customcranial remodeling device is being worn, and the frequency ofpredetermined head motions.

Various embodiments may comprise components integrally formed with thecustom cranial remodeling device by the additive manufacture device. Thecomponents may comprise one or more of apparatus for fastening thecranial remodeling device in place on the head, electronic transducers,and electronic sensors.

An embodiment of a custom headwear device to be worn on the head of asubject comprises: an inner layer shaped to contact the head of thesubject at predetermined areas, the inner layer deposited by an additivemanufacturing device; an outer layer deposited by the additivemanufacturing device; and the inner layer and the outer layer are eachformed by the additive manufacture device utilizing a device data filederived from a subject data file, the subject data file representativeof the shape of the head.

In various embodiments of the custom headwear device, the device datafile is derived by one or more processors: determining contour lines forthe custom headwear device on the head shape utilizing the data file;projecting the contour lines outward from the deformed head onto themodified shape; and utilizing the contour lines to produce the devicefile.

In various embodiments of the custom headwear device, the inner layercomprises portions positioned to contact the head at predeterminedsurface areas of the head.

In various embodiments of the custom headwear device, the inner layercomprises a plurality of separate portions, each portion configured tocontact one of a corresponding plurality of areas on the head.

In various embodiments of the custom headwear device, one or moreremovable manufacturing supports are deposited to facilitate additivemanufacture of the custom headwear device.

Various embodiments of the custom headwear device comprise at least oneintermediate layer between the inner layer and the outer layer, theintermediate layer deposited by the additive manufacturing device.

In various embodiments of the custom headwear device, the inner layer,the outer layer and the intermediate layer each comprise one or both ofdifferent strength and material properties.

Various embodiments of the custom headwear device comprise alignmentmarks deposited on the custom headwear device by the additivemanufacture device, the alignment marks aide fitting the customremodeling device.

Various embodiments of the custom headwear device comprise guidelinesprinted by the additive manufacture device on the custom remodelingdevice.

Various embodiments of the custom headwear device comprise a pluralityof different layers comprising the inner and outer layers and one ormore intermediate layers, the plurality of layers comprising one or moreof different strength properties, material properties, andconfigurations.

In various embodiments of the custom headwear device, at least one layerof the plurality of layers comprises a cellular configuration.

In various embodiments of the custom headwear device, at least one layerof the plurality of layers comprises carbon fibers integrated therein.

Various embodiments of the custom headwear device comprise one or moreelectronic sensors manufactured by the additive manufacture device intothe custom cranial remodeling device.

Various embodiments of the custom headwear device comprise one or moreelectronic sensors operable to determine pressure levels applied to thehead when the custom headwear device is worn on the head; and the one ormore electronic sensors are manufactured into the custom headwear deviceby the additive manufacture device.

Various embodiments of the custom headwear device comprise one or moreelectronic transducers manufactured into the custom headwear device bythe additive manufacture device.

In various embodiments of the custom headwear device, the one or moreelectronic transducers are useable to determine one or more of tilt andturn of the head, whether the custom cranial remodeling device is beingworn, and the frequency of predetermined head motions.

Various embodiments of the custom headwear device comprise componentsintegrally formed with the custom cranial remodeling device by theadditive manufacture device; and the components comprise one or more ofapparatus for fastening the cranial remodeling device in place on thehead, electronic transducers, and electronic sensors.

BRIEF DESCRIPTION OF THE DRAWING

The invention will be better understood by a reading of the followingdetailed description of embodiments of the invention in which likereference indicators designate like elements and in which:

FIG. 1 illustrates an embodiment of a point of service manufacturefacility;

FIG. 2 is a screen shot of a frontal view of the head of a subject;

FIG. 3 is a screen shot of a left side view of the head of FIG. 2 ;

FIG. 4 is a screen shot of the rear of the head of FIG. 2 ;

FIG. 5 is a screen shot of a perspective view of the head of FIG. 2having contour lines thereon;

FIG. 6 is a screen shot of the perspective view of the head as shown inFIG. 5 having a modified head shape juxtaposed thereon;

FIG. 7 is a screen shot of the perspective view of FIG. 6 further havingan image of a cranial remodeling device thereon and lines projectingfrom the contour lines through the cranial remodeling device;

FIGS. 8, 9, and 10 illustrate the direction of the projecting lines ofFIG. 7 from a top view, left side view and frontal view respectively;

FIG. 11 is a cross section through a portion of an embodiment of acranial remodeling device; and

FIG. 12 is a cross section of a cranial remodeling device taken alonglines 12-12 of FIG. 11 .

DETAILED DESCRIPTION

Turning now to FIG. 1 , a clinic 100 is shown provides a point ofservice manufacturing apparatus for the manufacture of cranialremodeling devices. At this point of service manufacture clinic, aninfant 101 that has plagiocephaly has a three-dimensional digital imagecaptured of its head by digital capture apparatus 103. Digital captureapparatus 103 may be one of a known apparatus that is used to capturethree-dimensional digital images of the entirety of a head. For example,digital capture apparatus 103 may use a laser or other beam emittingscanner of a type described in U.S. Pat. Nos. 6,572,572 and 6,340,353,both of which are assigned to the assignee of this invention. Digitalcapture apparatus 103 may alternatively comprise optical captureapparatus such as that described in U.S. Pat. Nos. 7,142,701, 7,162,075,7,245,743, 7,280,682, 7,305,369, 7,542,950, 8,103,088, and 8,217,993 allof which are also assigned to the assignee of this invention. Thedisclosures of all the above-listed patents are incorporated herein byreference.

Image capture apparatus 103 processes the captured data and generates acaptured head data file 105 for the subject's head. In addition, imagecapture apparatus 103 processes data file 105 to generate a modifiedhead data file 107. The head shape represented by modified head datafile 107 represents a desired or corrected head shape for the subject.The methodology for generating the modified head shape data file isdescribed in the above-identified patents and additionally in U.S. Pat.Nos. 8,442,288, 8,442,308, 8,472,686, 8,494,237, and 8,787,657 all ofwhich are assigned to the assignee of this invention. The disclosures ofthese additional patents are incorporated herein by reference.

The captured head data file 105 and modified head data file are bothaccessed by processor 109 executing program 111 to generate a devicedata file 113 that completely defines a custom cranial remodeling devicefor subject 101. The operation of processor 109 executing program 111 isdescribed in detail herein below.

Device data file 113 is provided to an additive manufacture device 115.Additive manufacture device 115 utilizes device data file 113 tomanufacture a custom cranial remodeling device 117 for subject 101.

Additive manufacture device 115, in one embodiment is a commerciallyavailable three-dimensional printer that is operable to deposit layersof material to form cranial remodeling device 117. It will be recognizedby those skilled in the art that there are various types of additivemanufacture devices that are commercially available and the presentinvention encompasses those various types of additive manufacturedevices.

The embodiment shown in FIG. 1 provides digital capture apparatus 103and additive manufacture device 115 at the same physical location. Inaddition, processor 109 may also be located at the same physicallocation or located remotely from the clinic 100 and data linked theretoto provide the effect of being located at clinic 100.

It will be further appreciated by those skilled in the art that althougha separate processor 109 is shown in FIG. 1 , processor 109 is merelyrepresentative and may comprise one or more processors that are eitherlocated at clinic 100 or at a remote location or some combinationthereof. Still further processor 109 may be incorporated into digitalcapture unit 103 such that the processor of digital capture unit alsoexecutes program 111 to generate device file 113.

Digital capture apparatus 103 operates on captured subject head datarepresenting the digital image of the head of subject 101 tomathematically remove the subject's body and other extraneousinformation to establish a subject data file. The digital image of thesubject's body is mathematically cropped or removed leaving just digitaldata representative of the digital image of the subject's head toprovide three-dimensional cropped subject data.

The three-dimensional cropped subject data is oriented into apredetermined standardized orientation for further processing to producea cropped and oriented data file that is referred to as the capturedhead data file 105.

It will be appreciated by those skilled in the art that in otherembodiments, program 111 may provide the cropping and orientationfunctions that are provided by digital capture apparatus 103.

Processor 109, executing program 111, utilizes captured head data file105 to generate curvature maps of the subject's head. A plurality ofdifferent types of curvature maps are generated by processor 109,executing program 111. Specific ones of the curvature maps are used tolocate specific curvatures and features for a cranial remodeling device.Program 111 is utilized to create, reference, and cross-reference thecurvature maps to determine an optimal position of a device contour.

The term “contour” as used herein is the shape that defines the what inthe past has been called “trim lines” for cranial remodeling devicesthat were formed by first thermoforming foam and plastic layers onto ahead model and then cutting or trimming the foam and plastic to a finalshape of the cranial remodeling device to be worn on the head of asubject.

The program identifies anthropometric landmarks to determine the contourof the device.

In the embodiment describe below, the cranial remodeling devicecomprises bottom and top contour lines 117 a, 117 b. The bottom contourline 117 a and the top contour line117 b are each calculated for cranialremodeling device 117 by processor 109 executing program 111 operatinginitially captured head data file 105.

Turning now to FIGS. 2 and 3 execution of program 111 to calculatebottom contour line 117 a is described first and then the execution ofprogram 111 to calculate top contour line 117 b is described.

FIG. 2 illustrates a curvature map 201 of a frontal view head of subject101. Program 111 is executable to determine a bottom anterior contourline segments or splines by first mathematically defining twoexocanthion locations 203 a, 203 b, the two frontozygomatics points 205a, 205 b on the head, and the glabella 207. Using these five points 203a, 203 b, 205 a, 205 b, 207 as a spatial reference, an ellipticalcylinder shape is used to create the orbit contour splines 209 a, 209 b.

Program 111 executed by processor 109 identifies the sagittal plane 215and uses sagittal plane 215 to identify the location of a key portion211 of cranial remodeling device 117. In the embodiment, program 111 asexecuted by processor 109 generates a contour for key portion 211. Keyportion 211 dips a predetermined distance below an orbital horizontalthat is identified by program 111.

Turning now to FIG. 3 , program 111 as executed by processor 109identifies a coronal plane 301 on the head and anterior temporalextension lines 303 a, 303 b are attached to the ends of the orbitalsplines 209 a, 209 b at the exocanthions 203 a, 203 b and continue downparallel to coronal plane 301.

Program 111, executed by processor 109 generates ear contours or splines305 for each ear. The location of ear contours 305 are determined bymathematically defining the top ear points 307, bottom ear points 309,front ear points 311 and back of ear points 313 and connecting thepoints 307, 309, 311, 313 for each ear with a curved spline 315. Inaddition to determining the ear contours 305, the midway point of thetotal length of the ear is defined.

The location, size and shape of the temporal piece contours 315 aredetermined by using the mathematically defined exocanthion points 203 a,203 b and front ear points 311. The location of the bottom 317 of thetemporal contour 315 is a predetermined portion x of the ears totallengthy above the bottom ear point 309.

Program 111, executed by processor 109, calculates a neck inflectionportion of the contour. The location of the neck inflection contourportion is determined by using a mathematically defined neck inflectionand the ears bottom points 309. The final location of the neckinflection point 321 is determined by calculating a weighted averagebetween the mathematically defined neck inflection point and the earbottom points 309.

Program 111, executed by processor 109, calculates an angle of the neckinflection contour is determined by calculating a guideline thatconnects the neck inflection point 321 to a chin point 323.

Program 111, executed by processor 109, calculates mastoid contours 331.The location, size and shape of the mastoid contours 331 are determinedby using the mathematically defined ear points 307, 309, 311, 313, theneck inflection point 321 and chin point 323. A guideline 325 thatconnects the neck inflection point 321 to the chin point 323 iscalculated. A line 331 perpendicular to the guideline 325 is placed apredetermined distance from the posterior ear point 313.

Curved contour portions 333 are each calculated, sized and positioned tobe tangent to the back of the ear spline 305 and contact both the neckinflection point 321 to guide line 325 and line 331. The shape of eachcurved contour portion 333 is different for each head.

In the embodiment, cranial remodeling device 117 further comprises a topcontour 117 b.

Program 111, executed by processor 109, identifies a point 221 of lowcurvature on the sagittal midline 223 above the frontal bones as thelocation of an anterior superior contour.

Program 111, executed by processor 109, identifies a point 401 of lowcurvature on the sagittal plane 223 above the Occipital bones as theheight location of the posterior superior as shown in FIG. 4 .

Program 111, executed by processor 109, determines an anterior cornerfront starting point 225 from a standard offset of sagittal plane 223.

Program 111, executed by processor 109, determines an anterior cornerlateral starting point 341 in the coronal direction utilizing curvaturesassociated with the coronal suture.

Program 111, executed by processor 109, determines a posterior cornerback starting point 405 in the sagittal direction by calculating astandard offset of the mathematically derived sagittal plane 223.

Program 111, executed by processor 109, determines a posterior cornerlateral starting point 351 in the coronal direction using the curvaturesassociated with the coronal plane 301.

Program 111, executed by processor 109, by performing the abovecalculations and operations, defines top contour 117 b and bottomcontour 117 a on the oriented head shape as shown in drawing figures andmost clearly shown in FIGS. 1 and 5 .

Once the top and bottom contours 117 b, 117 a are created on theunmodified head shape, program 111, executed by processor 109,juxtaposes modified head shape 600 onto unmodified head shape 200 asshown in FIG. 6 .

Program 111, executed by processor 109, utilized modified head shape 600to generate a multilayered cranial remodeling device 700 juxtaposed ontomodified head shape 600. At this point, multilayered cranial remodelingdevice 700 extends over substantially all of modified head shape 600 asshown in FIG. 7 .

Program 111, executed by processor 109, projects lines 701 from topcontour 117 b and bottom contour 117 a through juxtaposed modified headshape 600 and through juxtaposed multilayer cranial remodeling device700 as shown in FIG. 7 .

Lines 701 are projected from unmodified head shape 200. As shown inFIGS. 8, 9, and 10 , to maintain an optimal relationship to the modifiedhead shape 600, lines 701 are projected directly right and left forlateral contours 801 and front/back for anterior and posterior contours803. Where the right and left lines transition to the front and backlines 805 the projection of the lines is radial.

Program 111, executed by processor 109, utilizes projected lines 701 todefine bottom and top contours 117 a, 117 b onto multilayered cranialremodeling device 700 to generate a device file 113.

In generating device file 113, program 111, executed by processor 109,selects the properties of each of a plurality of layers for the cranialremodeling device 117.

Additive manufacture device 115 of FIG. 1 utilizes device file 113 tomanufacture a cranial remodeling device by depositing a plurality oflayers as shown in FIG. 11 . FIG. 11 is a cross-section of a portion ofa cranial remodeling device 117 and is intended to be representative ofembodiments of such a device. Other embodiments may have more or lesslayers deposited by additive manufacture.

One embodiment of a custom cranial remodeling device 117 to correct adeformed head of a subject comprises an inner layer 1101 shaped tocontact the head of the subject at predetermined areas. The inner layer1101 is deposited by additive manufacturing device 115 shown in FIG. 1 .Cranial remodeling device 117 comprises an outer layer 1103 deposited bythe additive manufacturing device 115. The inner layer 1101 and theouter layer 1103 are each formed by the additive manufacture deviceutilizing device data file 113 derived from a subject or captured headdata file 105. The subject data file 105 is representative of the shapeof the deformed head of the subject 101.

Device data file 113 determines the shape of the cranial remodelingdevice 117 to correct the shape of the deformed head.

In an embodiment, device data file 113 is derived from subject data file105 and a modified data file 107. The modified data file 107 isrepresentative of a modified head shape.

Device data file 113 is derived by one or more processors 109 operableto: determining contour lines 117 a, 117 b for custom cranial remodelingdevice 117 e on the deformed head shape 200 shown in FIGS. 2 through 10; juxtaposing a digital representation 600 of the modified shape on thedeformed head shape 200 as shown in FIGS. 6 and 7 ; projecting thecontour lines 117 a, 117 b outward from the deformed head shape 200 ontothe modified shape 600; and utilizing the contour lines to produce thedevice data file 113.

In various embodiments the inner layer comprises portions positioned tocontact the head at predetermined surface areas of the head.

In various embodiments, inner layer 1101 comprises a plurality ofseparate portions that are not shown in the drawing figures. Eachseparate portion of inner layer 1101 is configured to contact one of acorresponding plurality of areas on the head shape 200.

In various embodiments, cranial remodeling device 117 comprises one ormore removable manufacturing supports, that are not shown in the drawingfigures, to facilitate additive manufacture of custom cranial remodelingdevice 117. The supports are provided solely to facilitate additivemanufacture and are removed prior to utilization of cranial remodelingdevice 117. The supports may be of any convenient configuration and maybe comprised from an additive material that is easily dissolved or isotherwise easily removable from the finished cranial remodeling device.

In various embodiments, the inner layer 1101, the outer layer 1103 andthe intermediate layer 1105 each comprise one or both of differentstrength and material properties. Device data file 113 as generated byprocessor 109 executing program 111 automatically determines thematerial deposited for each layer 1101, 1103, 1105 and any configurationdetails for each layer 1101, 1103, 1105.

In various embodiments, cranial remodeling device 117 comprisesalignment marks deposited on the cranial remodeling device 117 byadditive manufacture device 115. The alignment marks aid a clinician infitting custom cranial remodeling device 117 to subject 101. Thealignment marks may be formed by incorporation of various landmarks suchas depressions or protrusions or other identifications formed into alayer and visible to a clinician.

One embodiment comprises a plurality of different layers comprisinginner layer 1101, outer layer 1103 and one or more intermediate layers1105, the plurality of layers comprising one or more of differentstrength properties, material properties, and configurations, each layer1101, 1103, 1105 of the plurality of layers is deposited by the additivemanufacturing device.

In various embodiments, at least one layer of the plurality of layerscomprises a cellular configuration as shown in FIG. 12 . Although arectangular cellular construction is shown in FIG. 12 , it will beunderstood by those skilled in the art, that various configurations maybe selected. By way of non-limiting example, the cellular constructionmay present a beehive cellular construction. The use of a cellularconstruction may present particular advantages for certain embodiments.For example, the use of a cellular construction may provide greaterstrength and a lighter weight cranial remodeling device.

In at least one embodiment, at least one layer of the plurality oflayers comprises carbon fibers integrated therein. For example, outerlayer 1103 may comprise carbon fibers to provide greater strength andlighter weight to cranial remodeling device 117.

By utilizing additive manufacture, one or more electronic sensors may beembedded in cranial remodeling device 117 as part of the additivemanufacture protocol presented by device data file 113.

The one or more electronic sensors may be operable to determine pressurelevels applied to the subject's head when custom cranial remodelingdevice 117 is worn.

The one or more electronic sensors may further be operable to confirmthat custom cranial remodeling device 117 is being correctly worn on thesubject's head.

In other embodiments one or more electronic transducers are manufacturedinto the custom cranial remodeling device 117 by the additivemanufacture device 115. The one or more electronic transducers may beuseable to determine one or more of tilt and turn of the subject's head,whether the custom cranial remodeling device 117 is being worn, and thefrequency of predetermined head motions.

Various embodiments may comprise components integrally formed with thecustom cranial remodeling device 117 by the additive manufacture device115. The components may comprise one or more of apparatus for fasteningthe cranial remodeling device in place on the head, electronictransducers, and electronic sensors.

Although the embodiments described above are for custom cranialremodeling devices, 117 other embodiments may be for custom headweardevices to be worn on the head of a subject. Embodiments of customheadwear devices may comprise: an inner layer 1101 shaped to contact thehead of the subject at predetermined areas, the inner layer deposited byan additive manufacturing device; an outer layer 1103 deposited by theadditive manufacturing device. The inner layer 1101 and the outer layer1103 are each formed by the additive manufacture device 115 utilizing adevice data file113 derived from a subject or captured head data file105. The subject data file 105 is representative of the shape of thehead.

In various embodiments of the custom headwear device, the device datafile is derived by one or more processors 109: determining contour lines117 a for the custom headwear device 117 on the head shape 200 utilizingdevice data file 113; projecting the contour lines 117 a outward fromthe head as shown in FIG. 7 ; and utilizing the contour line 117as toproduce the device file. It will be apparent to those skilled in the artthat if the custom headwear device 117 is not intended to be utilizedfor cranial remodeling, but, for example is a protective headwear devicethat there is no modified head shape 600 and the shape of the protectiveheadwear device 700 is juxtaposed directly onto the subject head shape200. The contour lines 117 a are then projected outward as shown in FIG.7 to provide contour lines for the protective headwear device and togenerate the corresponding custom headwear device data for use byadditive manufacture device 115.

In various embodiments of the custom headwear device 117, inner layer1101 comprises portions positioned to contact the head at predeterminedsurface areas of the head.

In various embodiments of the custom headwear device, inner layer 1101may comprise a plurality of separate portions, each portion configuredto contact one of a corresponding plurality of areas on the subject'shead.

In various embodiments of the custom headwear device 117, one or moreremovable manufacturing supports as described herein above are depositedto facilitate additive manufacture of the custom headwear device.

Various embodiments of the custom headwear device 117 comprise at leastone intermediate layer 1105 between the inner layer 1101 and the outerlayer 1103, the intermediate layer 1105 is deposited by the additivemanufacturing device.

In various embodiments of the custom headwear device 117, the innerlayer 1101, the outer layer1103, and the intermediate layer 1105 eachcomprise one or both of different strength and material properties.

Various embodiments of the custom headwear device 117 comprise alignmentmarks as described herein above.

Various embodiments of the custom headwear device 117 compriseguidelines printed by the additive manufacture device on the customheadwear device as described herein above.

Various embodiments of the custom headwear device comprise a pluralityof different layers comprising inner layer 1101, outer layer 1103, andone or more intermediate layers 1105, the plurality of layers comprisingone or more of different strength properties, material properties, andconfigurations.

In various embodiments of the custom headwear device 117, at least onelayer 1105 of the plurality of layers comprises a cellular configurationas shown in FIG. 12 and as described herein above.

In various embodiments of the custom headwear device 117, at least onelayer of the plurality of layers comprises carbon fibers integratedtherein.

Various embodiments of the custom headwear device 117 may comprise oneor more electronic sensors manufactured by the additive manufacturedevice into the custom headwear device.

Various embodiments of the custom headwear device comprise one or moreelectronic sensors operable to determine pressure levels applied to thehead when the custom headwear device is worn on the head; and the one ormore electronic sensors are manufactured into the custom headwear deviceby the additive manufacture device.

Various embodiments of the custom headwear device 117 comprise one ormore electronic transducers manufactured into the custom headwear deviceby the additive manufacture device.

In various embodiments of the custom headwear device 117, the one ormore electronic transducers are useable to determine one or more of tiltand turn of the head, whether the custom cranial remodeling device isbeing worn, and the frequency of predetermined head motions.

Various embodiments of the custom headwear device comprise componentsintegrally formed with the custom cranial remodeling device by theadditive manufacture device; and the components comprise one or more ofapparatus for fastening the cranial remodeling device in place on thehead, electronic transducers, and electronic sensors.

In various embodiments, the methods and apparatus described formanufacture of cranial remodeling devices may also be used tomanufacture custom headwear devices for subjects such as, by way ofnon-limiting example, sports helmets and protective helmets. In themanufacture of custom headwear devices, contour lines may be calculatedon a captured subject data file representative of the shape of thesubject's head that is captured utilizing one of digital image captureapparatus and scanning apparatus. The contour lines may be extendedoutward from the contour lines on the head image data representative ofthe subject's head through a calculated multi-layered headwear devicejuxtaposed onto the subject's head image data as described herein above.

The invention has been described in terms of various embodiments. Itwill be apparent to those skilled in the art that various modificationsmay be made without departing from the scope of the invention. It isintended that the invention be limited in scope only by the claimsappended hereto.

What is claimed is:
 1. A method for fabricating a custom cranialremodeling device for correction of cranial deformities in a subject'shead, said method comprising: providing a processor, said processoroperating on a three-dimensional head data file for a head shape of saidsubject's head to identify and utilize predetermined reference points onsaid head shape represented by data in said three-dimensional head datafile to determine one or more contour lines on said head shaperepresented by said three-dimensional head data file, said contour linesdefining peripheral edges of said custom cranial remodeling device;operating said processor to automatically to process said head data fileto produce a modified head shape data file for said head; operating saidprocessor to utilize said modified head shape data file to generate adevice shape for a said custom cranial remodeling device, said deviceshape having an interior surface to contact said head and an outersurface; said processor utilizing said contour lines to establishcorresponding inner and outer surface peripheral edges on said deviceshape for said custom cranial remodeling device to provide customizedinner and outer surfaces for said custom cranial remodeling device;utilizing said processor to generate a three-dimensional device datafile comprising said device shape of said custom cranial modeling devicecomprising said inner and outer surface peripheral edges; providing saidthree-dimensional device data file to an additive manufacturing device;and utilizing said additive manufacturing device to manufacture saidcustom cranial remodeling device from said three-dimensional device datafile.
 2. The method of claim 1, comprising: utilizing athree-dimensional printer as said additive manufacturing device.
 3. Themethod of claim 1, comprising: automatically orienting saidthree-dimensional head data file to a predetermined plane by firstautomatically identifying predetermined physical points on said headshape as represented by data in said three-dimensional head data fileand utilizing said two predetermined points to form a plane to whichsaid head shape is rotated to produce a standardized oriented head datafile.
 4. The method of claim 1, comprising: utilizing one of scanningapparatus and optical capture apparatus to generate saidthree-dimensional data file of said deformed head shape.
 5. The methodof claim 1 comprising: utilizing apparatus comprising a laser scanner togenerate said three-dimensional data file of said deformed head shape.6. The method of claim 1, comprising: utilizing a three-dimensionalprinter as said additive manufacturing device.
 7. The method of claim 1,comprising: capturing digital data for said three-dimensional head datafile from said head.
 8. The method of claim 1, comprising: generatingsaid three-dimensional head data file by capturing three-dimensionaldigital head data with one of digital image capture apparatus andscanning apparatus.
 9. The method of claim 8, wherein: scanningapparatus comprises a laser scanner.
 10. The method of claim 8comprising wherein: said digital image capture apparatus comprisesphotographic apparatus.
 11. The method of claim 10, comprising:utilizing a three-dimensional printer as said additive manufacturingdevice.